Ex Parte Libbus et al

Patent Trial and Appeal Board

Mar 14, 2016

12612494 (P.T.A.B. Mar. 14, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/612,494 11104/2009
45458 7590 03/16/2016
SCHWEGMAN LUNDBERG & WOESSNER/BSC
POBOX2938
MINNEAPOLIS, MN 55402
ImadLibbus
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
279.818US2 4531
EXAMINER
VO,TUNGT
ART UNIT PAPER NUMBER
2486
NOTIFICATION DATE DELIVERY MODE
03/16/2016 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address( es):
uspto@slwip.com
SLW@blackhillsip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte IMAD LIBBUS, ANDREW P. KRAMER, WILLIAM J. LINDER,
and JEFFREY E. STAHMANN1
Appeal2014-004631
Application 12/612,494
Technology Center 2400
Before KRISTEN L. DROESCH, TERRENCE W. MCMILLIN, and
MATTHEW J. MCNEILL, Administrative Patent Judges.
MCMILLIN, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision2 on appeal under 35 U.S.C. § 134(a) of the Final
rejection of claims 1-21, which are all the pending claims. Final Act. 2. We
have jurisdiction under 35 U.S.C. § 6(b ).
We affirm-in-part.
1 According to Appellants, the real party in interest is Cardiac Pacemakers,
Inc. App. Br. 2.
2 Our Decision refers to the Final Office Action mailed April 18, 2013
("Final Act."); Appellants' Appeal Brief filed October 4, 2013 ("App. Br.");
the Examiner's Answer mailed November 29, 2013 ("Ans."); Appellants'
Reply Brief filed January 29, 2014 ("Reply Br."); and the Specification filed
November 4, 2009 ("Spec.").
Appeal2014-004631
Application 12/612,494
REJECTIONS ON APPEAL
Claims 1-21 stand rejected under 35 U.S.C. § 102(e) as being
anticipated by Giftakis et al. (US 7,945,316 B2; issued May 17, 2011; filed
December 19, 2005) ("Giftakis"). Final Act. 2-7.
Claims 1, 4--9, 11-13, 16-19, and 21 stand rejected under 35 U.S.C. §
102(b) as being anticipated by Huiku (US 2005/0272984 Al, published Dec.
8, 2005) ("Huiku"). Final Act. 7-10.
THE CLAIMED INVENTION
According to Appellants, "[t]his application relates generally to
medical devices and, more particularly, to devices to process sensed neural
activity." Spec. 1:15-16. Sole independent claim 1 is directed to a device.
Claim 1 recites:
1. A device for providing neural markers for sensed
autonomic nervous system (ANS) activity, comprising:
a port to receive a neural activity signal representative of
the ANS activity; and
a feature extractor adapted to receive and process the
neural activity signal to extract a feature from the neural activity
signal and produce an ANS neural marker for the extracted
feature, wherein the ANS neural marker includes information for
the extracted feature, wherein the information for the extracted
feature includes an event correlated with the ANS neural marker;
and
a memory connected to the feature extractor and
configured to store, for each ANS neural marker, both an ANS
neural marker label and an event identification for the event
correlated with the ANS neural marker.
App. Br. 27.
2
Appeal2014-004631
Application 12/612,494
ANALYSIS
Rejection of Claims 1-21 as Anticipated by Giftakis
Claim 1
In the Appeal Brief, Appellants argue that Giftakis fails to disclose, "a
port to receive a neural activity signal representative of the ANS activity" as
recited in claim 1.3 App. Br. 12; Reply Br. 4--5. The Examiner cites Figure
33, ref.# 18 ("EEG Lead"), of Giftakis. Ans. 3; Final Act. 3. Figure 33 of
Giftakis depicts a, "cardiac and cranial leaded medical device implanted in a
patient that monitors cardiac, repository and brain parameters relating to
nervous system disorder." Giftakis 4:1--4; see also 6:14--15; 29:57---60.
Appellants acknowledge the EEG signal detects seizures and seizures are
associated with autonomic neuronal dysfunction. App. Br. 12. Thus,
Giftakis discloses a device with a port receiving a neural activity signal (the
EEG signal of central nervous activity in the brain) which is "representative"
of ANS activity.
Appellants argue, "Giftakis also does not store, for each ANS neural
marker, both an ANS neural marker label and an event identification." App.
Br. 13. The Examiner cites Figures 37 and 38 of Giftakis. Final Act. 3--4;
Ans. 11-12. Figure 37 of Giftakis is reproduced below.
3 Appellants argue the Examiner has not correctly interpreted "neural
activity signal" as used in claim 1. App. Br. 9-11; Reply Br. 2-3.
Appellants contend a correct interpretation requires that the signal be of
neural activity in the autonomic nervous system (ANS). Id. This is not
commensurate with the scope of the claim 1. Claim 1 only requires the
"neural activity signal [be] representative of the ANS activity." App. Br. 27
(emphasis added). In addition, the Specification provides neural activity can
be used as a "surrogate" for other physiological parameters. Spec. 6:25-27;
8:6-8. The Examiner applies the prior art in accordance with the broadest
reasonable interpretation of claim 1.
3
Appeal2014-004631
Application 12/612,494
No
806
910
Measure
Impedance
MV c:a1eulation
Yes
Insert tlme .. 1amp. 1---~
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B1B aw
822
Measure
EEG
EEG calculation
Yes
Format diagnostic
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914
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Figure 37
824
02.B
Figure 37 of Giftakis depicts receiving EEG data (ref. # 828), formatting the
diagnostic data (ref.# 812), inserting a time stamp (ref.# 810), and storing
the diagnostic data in memory (ref.# 814). Figure 38 of Giftakis is
reproduced below.
4
Appeal2014-004631
Application 12/612,494
~~
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__________________________ ,...,.,, _______ __
Figure 38 of Giftakis depicts "exemplary physiological data." Giftakis 6:24;
14: 14--15. The Specification provides the following description for a
"neural marker:"
The neural marker 433 includes information regarding the
extracted feature. In various embodiments, the marker includes
one or more of a label for the feature, a time stamp, a location of
where the neural signal was sensed, an identification for the
neural pathway type (such as efferent, afferent), an amplitude for
the sensed neural signal, a frequency for the sensed neural signal,
and an event, such as an applied therapy or sensed event,
correlated with the sensed neural signal. Other information can
be provided in the neural marker.
Spec. 15:18-24. We agree with the Examiner that Figures 37 and 38 of
Giftakis disclose storing, for each ANS neural marker, both an ANS neural
marker label and an event identification. We are not persuaded of error in
the rejection of claim 1.
5
Appeal2014-004631
Application 12/612,494
Claim 4
Claim 4 recites, "[t]he device of claim 1, wherein the feature extractor
includes a filter for filtering the neural activity signal to extract the feature."
App. Br. 27. Appellants argue Giftakis does not disclose a filter for filtering
the neural activity signal. App. Br. 13; Reply Br. 7. The Examiner cites
Figure 33, ref. # 750 ("MV LPF" (minute ventilation low pass filter)) of
Giftakis. Final Act. 4; Ans. 12-13. This filter is in the circuit connected to
the cardiac leads which "allow detection of a neurological event and the
recording of data and signals pre and post event." Giftakis, Figures 6, 33;
11:67-12: 1; 29:58-59. We are not persuaded of error in the rejection of
claim 4.
Claim 5
Claim 5 recites, "[t]he device of claim 4, wherein the filter is
configured to apply a moving window average to the neural activity signal."
App. Br. 27. The Examiner cites Figure 37, ref.# 806 ("HR avg.") and ref.
# 820 ("MV avg.") of Giftakis. Final Act. 4; Ans. 13. See also, Giftakis
31 :46-48 ("At block 804, a rate stability measurement is made on each
cardiac interval utilizing a heart rate average from block 806"). Appellants
contend the activity signal has not been shown to be a neural activity signal.
Reply Br. 8. But, as shown above, the cardiac leads of Giftakis detect
neurological activity. Giftakis 11:64--12: 1. We are not persuaded of error in
the rejection of claim 5.
6
Appeal2014-004631
Application 12/612,494
Claim 6
Claim 6 recites, "[t]he device of claim 4, wherein the filter is
configured to provide a logarithmic average to the neural activity signal."
App. Br. 28. The Examiner cites Figure 37, ref.# 806 ("HR avg."), of
Giftakis. Final Act. 4; Ans. 13. In the Examiner's Answer, the Examiner
states, "note a filter inherently has a logarithmic." Ans. 13. "Under the
principles of inherency, if the prior art necessarily functions in accordance
with, or includes, the claimed limitations, it anticipates." In re Cruciferous
Sprout Litig., 301 F.3d 1343, 1349 (Fed. Cir. 2002) (citations and internal
quotation marks omitted). The Examiner has not shown Giftakis discloses
or necessarily functions in accordance with, or includes, a filter configured
to provide a logarithmic average to the neural activity signal. On this record,
we reverse the rejection of claim 6 as anticipated by Giftakis.
Claim 7
Claim 7 recites, "[t]he device of claim 4, wherein the filter is
configured to average neural activity signals aligned to an index event."
App. Br. 28. The Examiner cites Figure 37, ref.# 806 ("HR avg."), of
Giftakis. Final Act. 4; Ans. 14. In the Examiner's Answer, the Examiner
states:
It 1s submitted that Giftakis teaches wherein the filter is
configured to average neural activity signals aligned to an index
event (806 of fig. 37, note the device controls a flag set by the
seizure-detection algorithm operating on EEG signals. The flag
is a real-time indicator of the subject's seizure state (l=in EEG
detection state; O=out of EEG detection state)).
7
Appeal2014-004631
Application 12/612,494
Ans. 14. In the Reply Brief, Appellants state: "it is not clear how the
Examiner arrives on a seizure state to be an 'average' of neural activity
signals aligned to an index event." Reply Br. 9. We agree with Appellants.
Therefore, on this record, we reverse the rejection of claim 7 as anticipated
by Giftakis.
Claim 9
Claim 9 recites, "[t]he device of claim 1, wherein the feature extractor
includes a comparator to compare the extracted feature of the neural activity
signal to at least one programmable value." App. Br. 28. In response to
Appellants' argument that Giftakis does not disclose the elements of claim 9,
the Examiner states:
It is submitted that Giftakis teaches wherein the feature extractor
includes a comparator to compare the extracted feature of the
neural activity signal to at least one programmable value (fig. 39,
e.g.[,] 750 of fig. 33, note the EEG monitoring may be
programmed to provide alerts when a neurological event has
exceeded a pre-determined duration or severity. In figure 33, it
will be apparent to those of ordinary skill in the art that CPU 732
functions to control the timed operation of sense amplifier circuit
724 under control of programming stored in RAM/ROM unit
730).
Ans. 14. In the Reply Brief, Appellants state: "The Examiner again relies on
brain monitoring. This is not comparing an extracted feature of the neural
activity signal (representative of ANS activity) to programmable value."
Reply Br. 9. This is essentially the same argument made, discussed, and
rejected above with regard to claim 1. We are not persuaded of error in the
rejection of claim 9.
8
Appeal2014-004631
Application 12/612,494
Claim 14and15
Claims 14 and 15 are dependent on claim 13. Claim 13 recites, "[t]he
device of claim 1, further comprising: a display; and a controller adapted to
communicate with the memory and the display to provide a representation of
the ANS neural marker label and the event on the display." App. Br. 28.
Claim 14 recites, "[t]he device of claim 13, wherein the representation of the
neural marker includes a time stamp and the ANS neural marker label." Id.
Claim 15 recites, "[t]he device of claim 13, wherein the representation of the
ANS neural marker includes an image of a portion of the sensed neural
activity signal corresponding to the ANS neural marker." Id. at 29. The
Appellants argue the rejection of claims 14 and 15 are improper for the same
reasons discussed above in relation to claim 1. We sustain the rejection of
claims 14 and 15 for the reasons stated above with regard to claim 1.
Claim 19
Claim 19 recites, "[t]he device of claim 1, wherein the information for
the extracted feature includes an ANS activity location, and the memory is
configured to store, for each ANS neural marker, the ANS activity location,
the ANS neural marker label, and the event identification." App. Br. 29. In
the Examiner's Answer, the Examiner states:
It is submitted that Giftakis teaches wherein the information for
the extracted feature includes an ANS activity location, and the
memory is configured to store, for each ANS neural marker, the
ANS activity location, the ANS neural marker label, and the
event identification (730 of fig. 33, 810-814 of fig. 37, note
Format Diagnostic Data block 812 formats the data from the
cardiac and respiration monitoring channels, adds a time stamp
([i.e.], date and time) and provides the data to block 814 where
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Appeal2014-004631
Application 12/612,494
the data is stored in RAivI, SRAivI or ivIRAivI memory for later
retrieval by a clinician via telemetry).
Ans. 16. See also, Giftakis, Fig. 38 (reproduced above). Appellants fail to
explain how the Examiner erred. App. Br. 17; Reply Br. 10---11. We are not
persuaded of error in the rejection of claim 19.
Claim 20
Claim 20 recites:
The device of claim 1, wherein the information for the
extracted feature includes a neural pathway type of a nerve on
which the nerve traffic is sensed, and the memory is configured
to store, for each ANS neural marker, the neural pathway type,
the ANS neural marker label, and the event identification.
App. Br. 29. Appellants contend the Examiner does not identify a "neural
pathway type of a nerve on which the nerve traffic is sensed" disclosed in
Giftakis. Reply Br. 11. But, the Examiner identifies the EEG signal of
Figure 3 8 of Giftakis. Ans. 16. This identifies the neural pathway type as a
brain or central nervous system pathway. We are not persuaded of error in
the rejection of claim 20.
The pending claims not specifically addressed above (claims 2, 3, 8,
10---13, 16-18, and 21) are not separately argued by Appellants.
Accordingly, the rejections of claims 1-5 and 8-21 as anticipated by
Giftakis are affirmed and the rejections of claims 6 and 7 as anticipated by
Giftakis are reversed.
10
Appeal2014-004631
Application 12/612,494
Rejection oi Ciaims 6 and 7 as Anticipated by Huiku
We limit our analysis of rejection of the claims as anticipated by
Huiku to claims 6 and 7 which are the only claims for which we are not
sustaining the rejection as anticipated by Giftakis.
Claim 6
Claim 6 recites, "[t]he device of claim 4, wherein the filter is
configured to provide a logarithmic average to the neural activity signal."
App. Br. 28. The Examiner cites paragraph 74 of Huiku. Final Act. 8; Ans.
20. In the Examiner's Answer, the Examiner states, "[i]t is submitted that
Huiku teaches wherein the filter is configured to provide a logarithmic
average to the neural activity signal ([0074]) the normalized signal, the
logarithmic average is inherently in the filter)." Ans. 20 (emphasis added).
Paragraph 7 4 of Huiku does not include any explicit disclosure relating to
providing a logarithmic average of a neural activity signal. "Under the
principles of inherency, if the prior art necessarily functions in accordance
with, or includes, the claimed limitations, it anticipates." Cruciferous Sprout
Litig., 301 F.3d at 1349 (citations and internal quotation marks omitted).
The Examiner has not shown Huiku discloses or necessarily functions in
accordance with, or includes, a filter configured to provide a logarithmic
average of the neural activity signal. On this record, we reverse the rejection
of claim 6 as anticipated by Huiku.
Claim 7
Claim 7 recites, "[t]he device of claim 4, wherein the filter is
configured to average neural activity signals aligned to an index event."
App. Br. 28. The Examiner cites Figure 7 and paragraphs 61 and 80 of
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Appeal2014-004631
Application 12/612,494
Huiku. Final Act. 8; Ans. 20-21. In the Examiner's Answer, the Examiner
states:
It is submitted that Huiku teaches wherein the filter is configured
to average neural activity signals aligned to an index event
(e.g.[,] fig. 7, [0080], note [0061] the output value of the
transformation is then obtained by means of the output array as
the index value that corresponds to the location of the new value
in the input array, and the index value that corresponds to the
location of the new value in the sorted input array).
Ans. 21. In the Reply Brief, Appellants state:
Appellants disagree. FIG. 7 does not show a filter, but rather
show[ s] an example of count values ([0080]). Paragraph [0080]
refers to an index of analgesia, which is identified as a
normalized value to a fixed range. Paragraph [0061] refers to an
index value of an output array. The Examiner appears to cite
these paragraphs simply for the reason that they include the word
"index." These paragraphs do not disclose average neural
activity signals aligned to an index event.
Reply Br. 15. We agree with Appellants. The cited figure and passages of
Huiku do not disclose the disputed limitation of claim 7. On this record, we
reverse the rejection of claim 7 as anticipated by Huiku.
DECISION
The rejections of claims 1-5 and 8-21 are affirmed.
The rejections of claims 6 and 7 are reversed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED-IN-PART
12